NCT06177743

Brief Summary

The objective of this study is to evaluate the effectiveness and safety of Coroflex ISAR NEO stents in comparison to other drug-eluting stents (DES) in real-world practice.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jan 2025Dec 2030

First Submitted

Initial submission to the registry

December 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 9, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

December 11, 2023

Last Update Submit

June 10, 2025

Conditions

Coronary Artery StenosisCoronary Artery Disease

Keywords

percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)

    the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

    12 months

Secondary Outcomes (10)

  • the event rate of all cause death

    5 years

  • the event rate of cardiac death

    5 years

  • the event rate of myocardial infarction

    5 years

  • the composite event rate of death, or myocardial infarction (MI)

    5 years

  • the composite event rate of cardiac death, or myocardial infarction (MI)

    5 years

  • +5 more secondary outcomes

Study Arms (1)

Coroflex ISAR NEO

Patients receiving percutaneous coronary intervention with Coroflex ISAR NEO stents

Device: Coroflex ISAR NEO stent

Interventions

Coroflex ISAR NEO stentDEVICE

Percutaneous coronary intervention with Coroflex ISAR NEO stent

Coroflex ISAR NEO

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving Coroflex ISAR NEO stents.

You may qualify if:

  • Patients ≥ 19 years old
  • Patients receiving Coroflex ISAR NEO stents.
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

You may not qualify if:

  • Patients with a mixture of other DESs
  • Terminal illness with life expectancy \<1 year.
  • Patients with cardiogenic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

RECRUITING

Bucheon Sejong Hospital

Bucheon-si, South Korea

NOT YET RECRUITING

The Catholic Univ. of Korea BUCHEON ST.Mary's hospital

Bucheon-si, South Korea

NOT YET RECRUITING

Veterans Hospital

Daegu, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

NOT YET RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, South Korea

NOT YET RECRUITING

Myongji Hospital

Ilsan, South Korea

NOT YET RECRUITING

Sejong Chungnam National University Hospital

Sejong, South Korea

RECRUITING

Seoul National University Boramae Medical Center

Seoul, South Korea

NOT YET RECRUITING

The Catholic university of Korea, ST. Vincent's Hospital

Suwon, South Korea

RECRUITING

Uijeongbu Eulji Medical Center

Uijeongbu-si, South Korea

WITHDRAWN

MeSH Terms

Conditions

Coronary StenosisCoronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Central Study Contacts

Jung-Hee Ham, Project manager

CONTACT

82230104728cvcrc5@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 20, 2023

Study Start

January 9, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2030

Last Updated

June 11, 2025

Record last verified: 2025-06

Locations

KR(11)